Extension of the EU MDR transition period – Recent Developments

With EU Members arguing legislative measures had to be put forward to help prevent potential medical device shortages, the European Commissioner for Health and Safety proposed measures to extend the transition rules of the Medical Device Regulation (MDR) at the EPSCO Council meeting on 9 December 2022

The EU Comission published, in January 2023, a press release with the headline: “Public health: more time to certify medical devices to mitigate risks of shortages”, indicating the Comission proposal to introduce a longer transition period to adapt to the new rules, as expected under the MDR.

The availability of medical devices in Europe, with guaranteed safety, is a priority, with the EU Comission claiming it will not change any performance or safety requirements already established in the legislation, only amending transitional provisions. This will give manufacturers more time to transition from the previous legislation and achieve the objective of complying with the requirements of the MDR.

The length of the proposed extension of the transition periods depends on the type of device and its risk.

The proposal extends the validity of certificates issued up until 26 May 2021, the day when the MDR became applicable. For devices covered by a certificate or declaration of conformity issued before 26 May 2021, the transition period to the MDR is extended from 26 May 2024 to 31 December 2027 for higher risk devices (Class III and IIb implantable) and until 31 December 2028 for medium and lower risk devices (Class IIb, IIa, Im, Is, Ir).

The “sell-off” date – the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn – is also proposed to be removed, guaranteeing that safe and essential devices that are already marketed stay available for patients and healthcare systems.

It is important, however, to mention that the extension of the current transition period laid down in Article 120 of the MDR is subject to certain conditions, so that only manufacturers that have already taken steps to transition to the rules provided for by the MDR will benefit from this additional time.

The EU is expected to adopt the proposed initiative through a fast-track procedure. The proposal has already been approved without any changes by the Council, and it’s now up to European Parliament.

The live progress of this procedure 2023/0005/COD can be tracked here.